Status:
TERMINATED
Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation
Lead Sponsor:
TikoMed AB
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This is a Phase II open, randomized, active comparator-controlled multi center study in patients with severe type-1 diabetes. This is a two-armed study where patients are randomized in a 2:1 ratio bet...
Eligibility Criteria
Inclusion
- Patient on a waiting list for islet transplantation
- Male and female patients age 18 to 60 years of age.
- Ability to understand and provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Clinical history compatible with type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years at the time of enrolment.
- Documented C-peptide \<0.1 nmol/L before first islet transplantation (stimulated in response to a MMTT or other confirmatory method).
- All subjects must have received medical treatment of their diabetes under the guidance from an experienced endocrinologist. If not previously transplanted the patient must also have;
- At least one episode of severe hypoglycemia in the past 1 year defined as an event with at least one of the following symptoms; memory loss, confusion, uncontrollable behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness, or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood/plasma glucose level \< 54 mg/dl \[3.0 mmol/L\] or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration OR
- Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more.
Exclusion
- Patients with prior organ transplants other than a kidney graft and/or islets. A previous pancreas transplant can be accepted if it failed within the first week due to thrombosis and the graft was removed.
- Patients with body mass index (BMI) \> 30.
- Insulin requirement \> 0.7 Unit/kg/day at screening.
- Consistently abnormal liver function tests (\> 1.5 x ULN on two consecutive measurements \> 2 weeks apart) at screening.
- Proliferative untreated diabetic retinopathy
- Increased risk for thrombosis (ex. homozygous APC-resistance) or bleeding (INR\>1.5)
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- Patients with increased cardiac risk defined as;
- unstable coronary artery disease requiring hospitalization or revascularization within 6 months prior to baseline visit
- chronic heart failure which required hospitalization 30 days prior to baseline visit
- Patients with active infections, unless treatment is not judged necessary by the investigators
- Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
- Patients with active peptic ulcer disease, symptomatic gallstones or portal hypertension.
- Patients who are pregnant or breastfeeding, or who intend to become pregnant.
- Patients of childbearing potential not willing to use adequate double contraception with \< 1% failure rate after the screening visit until the last visit.
- Active alcohol or substance abuse
- Patients with evidence of high-level sensitization (PRA\> 50% with flow cytometry).
- Patients with psychological conditions that make it unsafe to undergo islet transplantation or which preclude compliance with prescribed therapy
- HbA1c \> IFCC 100 mmol/mol, at screening.
- Patients with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with IBsolvMIR.
- Patients participating in or having participated in any other clinical drug studies in the past four weeks.
- History of bleeding disorders
- History of severe hypersensitivity
- Previous known heparin-induced thrombocytopenia (HIT)
- Patients with severe hepatic or renal impairment
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03867851
Start Date
February 8 2021
End Date
May 13 2024
Last Update
May 16 2024
Active Locations (5)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2300 RC
2
Oslo Universitetssykehus HF
Oslo, Norway
3
Sahlgrenska sjukhuset
Gothenburg, Sweden
4
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden